Medtronic Published: September 16, 2020
Job Type
Category
Level of education
Masters
Spoken Language needed
Hebrew, English
Level of Hebrew
Medium
Location of job
Yokneam
How many relevant years experience do you require for the role:
2 years

Description

Our Gastrointestinal and Hepatology (GIH) business offers technologies to help with early detection and treatment of gastrointestinal diseases and cancers and focuses on reducing complications through patient monitoring.

As a Senior Regulatory Affairs Specialist you will be responsible for developing and executing strategies for worldwide governmental approval to introduce new products (Class II & III) and maintain existing products to market, provides advice on regulatory requirements. You will prepare worldwide submissions and negotiate their approval with the agencies.

In addition, this position also assists with the mentoring and training of other regulatory affairs associates including providing work direction on projects of large scale with significant business impact.

A Day in the Life:

Team with business unit Regulatory Affair Specialists (RAS) and international regulatory staffs to provide regulatory support for new products/therapies and changes to existing products. Work with RAS, engineers and technical experts to resolve potential regulatory issues and questions from regulatory agencies.

Prepare submissions for new products and product changes as required to ensure timely approvals for clinical studies and market release. Review significant product submissions with manager and work on submission with regional counterparts.

Provide support to currently marketed products as necessary. This includes reviewing labeling, promotional material, product changes and documentation for changes requiring government approval. Prepare submissions and reports for international agencies as required by product status.

Interact directly and/or indirectly with international regulatory agencies on most projects/products at reviewer level. Review significant submission decisions/content issues with manager.

Support regulatory compliance activities, including manufacturing site registration, GMP audit, post-market vigilance reporting, product recalls, etc., as needed.

Maintain proficiency in worldwide regulatory requirements; establish and maintain good relationships with international agency personnel and business units.

Provide business and product information to international regulatory staffs to enable development of strategies and requirements and communicate that information to business teams.

Provide feedback and on-going support to product development teams for international regulatory issues and questions.

Ensure personal understanding of all quality policy/system items that are personally applicable. Follow all work/quality procedures to ensure quality system compliance and high-quality work.

May mentor or supervise other RAS, as directed by manager.

Requirements

Must Have:
- Bachelor’s degree
- Minimum 4 years of experience in regulatory affairs or the medical device industry OR minimum 2 years of experience in regulatory affairs in the medical device industry with advanced degree

Nice to Have:
- 5+ years medical device industry experience
- Experience with Class II/III medical devices
- Experience with medical device global product registrations/ submissions: US FDA 510(k)s/ PMAs, EU Tech Files, Health Canada license applications, Shonin (Japan PMDA), China NMPA, APAC and Latin America submissions.
- Experience performing advertising and promotion reviews for medical devices
- Medtronic product development experience
- Clinical or statistical experience
- Experience with international regulatory agency requirements, harmonized IEC/ISO/ GHTF standards.
- Strong communication and project management skills
- Effective interpersonal skills to be a good team member and mentor
- Ability to comprehend principles of engineering, physiology and medical device use. Good analytical thinking skills.
- Ability to effectively manage multiple projects and priorities.
- Proficient computer skills
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